Clinical trial · Interventional
Impact Of Intermittent And Water-Only Fasting On Gene Expression And Tumor Markers In Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This randomized controlled trial investigates the effects of intermittent fasting and water-only fasting on gene expression, tumor markers, quality of life, and chemotherapy tolerance in breast cancer patients receiving chemotherapy. Breast cancer remains the most commonly diagnosed cancer worldwide, and while chemotherapy constitutes standard treatment, it is frequently accompanied by significant adverse effects including cachexia and immunosuppression. Fasting has emerged as a promising complementary approach that may enhance chemotherapy efficacy while protecting healthy cells from treatment-related toxicity. The study will enroll 60 female breast cancer patients from INOR, Abbottabad, who will be randomly assigned to one of four groups: conventional chemotherapy alone, chemotherapy combined with intermittent fasting (23:1 hour fasting to eating ratio) plus routine diet, chemotherapy combined with intermittent fasting plus ketogenic diet, or chemotherapy combined with water-only fasting for two weeks. Blood samples will be collected before and after interventions to assess tumor marker CA 15-3, CD4+ and CD8+ T cell counts, oxidative stress marker malondialdehyde, inflammatory markers including TNF-α and neutrophil-lymphocyte ratio, Glasgow Prognostic Score, and metabolic regulators AMPK and pyruvate dehydrogenase. Quality of life will be evaluated using the validated FACT-B questionnaire, while chemotherapy tolerance will be assessed through symptom severity surveys. The study hypothesizes that combining fasting regimens with standard chemotherapy will enhance anti-tumor effects, improve immune surveillance mechanisms, and ultimately contribute to better prognostic outcomes in breast cancer patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional Chemotherapy | Drug | — | UNRESOLVED |
| Intermittent Fasting (23:1 Regimen) | Behavioral | — | UNRESOLVED |
| Ketogenic Diet | Dietary Supplement | — | UNRESOLVED |
| Water-Only Fasting | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Conventional Chemotherapy (Control Group)
- description
- Participants receive conventional chemotherapy treatment according to standard protocols at INOR, Abbottabad, with no dietary restrictions or fasting interventions. Patients consume their routine diet throughout the 4-week study period. Blood samples are collected at baseline and after 4 weeks for biomarker analysis. This group serves as the control arm against which the three fasting intervention groups will be compared.
- interventionNames
- Drug: Conventional Chemotherapy
- type
- EXPERIMENTAL
- label
- Intermittent Fasting + Routine Diet
- description
- Participants receive standard chemotherapy alongside an intermittent fasting regimen consisting of 23 hours of fasting with a 1-hour eating period daily for 30 consecutive days. During the 1-hour eating window, participants consume one routine meal per day consisting of their usual diet without specific dietary modifications. No food or calorie-containing beverages are consumed during the 23-hour fasting period; only water and zero-calorie drinks are permitted. Blood samples are collected at baseline and after completion of the 30-day intervention period. This arm evaluates the effects of intermittent fasting alone without dietary composition changes.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients aged 18 to 50 years * Histologically confirmed breast cancer (any TNM stage) * Currently receiving chemotherapy treatment at INOR, Abbottabad * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 * Body mass index (BMI) ≥ 24 kg/m² * Willing and able to provide written informed consent * Willing to comply with the assigned fasting and dietary interventions Exclusion Criteria: * Distant metastasis to liver or kidneys * ECOG performance status of 3 or 4 * Uncontrolled systemic diseases including cardiovascular disease, lung disease, or clinically confirmed metabolic disease * Human immunodeficiency virus (HIV) infection, chronic hepatitis B, hepatitis C, or other active infections clinically confirmed * Pregnant or lactating women * Concurrent participation in another interventional clinical trial * Inability to comply with fasting protocols due to medical or psychological reasons * Known contraindications to fasting including but not limited to eating disorders, severe malnutrition, or uncontrolled diabetes mellitus * Use of medications that may interfere with fasting or ketogenic diet (e.g., insulin, oral hypoglycemic agents requiring food intake) * Any condition that in the opinion of the investigator would compromise the safety of the participant or the integrity of the study
References
Publications (7)
- BACKGROUNDMarquez J, Flores J, Kim AH, Nyamaa B, Nguyen ATT, Park N, Han J. Rescue of TCA Cycle Dysfunction for Cancer Therapy. J Clin Med. 2019 Dec 6;8(12):2161. doi: 10.3390/jcm8122161. PMID 31817761
- BACKGROUNDGhosn B, Benisi-Kohansal S, Ebrahimpour-Koujan S, Azadbakht L, Esmaillzadeh A. Association between healthy lifestyle score and breast cancer. Nutr J. 2020 Jan 14;19(1):4. doi: 10.1186/s12937-020-0520-9. PMID 31937325
- BACKGROUNDSundaram S, Yan L. Time-restricted feeding mitigates high-fat diet-enhanced mammary tumorigenesis in MMTV-PyMT mice. Nutr Res. 2018 Nov;59:72-79. doi: 10.1016/j.nutres.2018.07.014. Epub 2018 Jul 31. PMID 30442235
- BACKGROUNDTang X, Li G, Shi L, Su F, Qian M, Liu Z, Meng Y, Sun S, Li J, Liu B. Combined intermittent fasting and ERK inhibition enhance the anti-tumor effects of chemotherapy via the GSK3beta-SIRT7 axis. Nat Commun. 2021 Aug 25;12(1):5058. doi: 10.1038/s41467-021-25274-3. PMID 34433808
- BACKGROUNDWilhelmi de Toledo F, Grundler F, Bergouignan A, Drinda S, Michalsen A. Safety, health improvement and well-being during a 4 to 21-day fasting period in an observational study including 1422 subjects. PLoS One. 2019 Jan 2;14(1):e0209353. doi: 10.1371/journal.pone.0209353. eCollection 2019. PMID 30601864
- BACKGROUNDRiedinger CJ, Kimball KJ, Kilgore LC, Bell CW, Heidel RE, Boone JD. Water only fasting and its effect on chemotherapy administration in gynecologic malignancies. Gynecol Oncol. 2020 Dec;159(3):799-803. doi: 10.1016/j.ygyno.2020.09.008. Epub 2020 Sep 18. PMID 32958269
- BACKGROUNDMyers TR, Zittel M, Goldhamer AC. Follow-up of water-only fasting and an exclusively plant food diet in the management of stage IIIa, low-grade follicular lymphoma. BMJ Case Rep. 2018 Aug 9;2018:bcr2018225520. doi: 10.1136/bcr-2018-225520. No abstract available.